In February there were two new drug approvals by the FDA we deemed specific to the specialty market. In addition, there were two supplemental drug approvals. The FDA had acted on assignment of new PDUFA dates for three new products for review. Finally, there was one complete response letter issued.

Drugs included in this review are generally regarded by the industry as specialty drugs. Qualifiers may include anticipated administration by a professional, distribution by a specialty pharmacy or submission and reimbursement under the medical claim or Medicare Part B.

New Specialty Drug Approvals – New FDA drug approvals in the previous month

Drug Name

Manufacturer

Route of Administration

Indication

Approval Date

JEUVEAU (prabotulinumtoxina-xvfs)

EVOLUS

Intramuscular

The temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients

02/01/2019

CABLIVI

(caplacizumab-yhdp)

ABLYNX NV

Intravenous or subcutaneous

The treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy

02/06/2019

HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk)

GENENTECH

Subcutaneous

The treatment of HER2-overexpressing breast cancer. (1.1, 1.2) Select patients for therapy based on an FDA-approved companion diagnostic for trastuzumab

The adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection

02/15/2019

LONSURF®

(trifluridine and tipiracil)

TAIHO ONCOLOGY

Oral

The treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

PDUFA: Prescription Drug User Fee Act: a law passed in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. By collecting the fee, the FDA is required to meet benchmarks related to the speed of the NDA/BLA review process

PDUFA Date: deadlines for the FDA to approve new drugs, typically 10 months from NDA/BLA completions, drugs selected for priority review may be allotted 6 months

Laura Benson

Prior to joining RJ Health in May of 2017, Laura obtained pharmacy practice experience at multiple practice sites including hospital, long-term care, and retail settings. Laura works with the development of analytic methodology, implementation, and reporting for our various clients in the RJ Health's Analytics Department.